Effectiveness of Electrical Vestibular Nerve Stimulation in the Management of Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- To evaluate the ability of the Modius Mood device, relative to the sham control group, in reducing the severity of depression at 8 weeks
研究概览
简要总结
Trial title: Effectiveness of Electrical Vestibular Nerve Stimulation in the Management of Depression
The aim of this study: To better evaluate the efficacy of non-invasive electrical vestibular nerve stimulation (VeNS) as a method of treating Depression, as compared to a sham control.
Allocation: Randomized to either active device or control device usage.
Endpoint classification: Efficacy Study Intervention Model: Parallel Assignment in 1:1 active to control allocation
Sample size: The aim is to recruit a total of up to 60 participants. The study will last 12 weeks in total for each subject.
详细描述
This double blind randomized controlled trial will enroll up to 60 subjects and will be conducted at the NRI Institute of Medical Sciences. The study will be randomized for a 8-week period with a 1:1 active to sham device allocation. Each participant will complete 5 stimulation sessions per week under the supervision of a researcher at the Department of Physiology. Each session will be 30 minutes on the day of usage. The scheduled study events are to be undertaken at the following timepoints:
- Baseline: Study Visit 1 (0-week timepoint for enrolment)
- Study Visit 2 (2-week timepoint)
- Study Visit 3 (4-week timepoint)
- Study Visit 4 (6-week timepoint)
- End of Study: Study Visit 5 (8-week timepoint)
- Post-intervention follow-up at 4 weeks (12-week timepoint)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed Informed Consent
- •Male or female, age ≥ 18 years and ≤ 80 years at the time of signing informed consent
- •PHQ-9 score of >/=10 at screening
- •On anti-depressant medication to treat depression (participant must only be on one Selective Serotonin or Norepinephrine Reuptake Inhibitor (SSRI/SNRI) for at least 1 year prior to baseline visit, and no longer than 5 years
- •Stable dose of anti-depressant (SSRI/SNRI) medication to treat depression, 3 months prior to baseline appointment
- •Stable medication regime for at least 4 weeks prior to the baseline visit
- •Can speak / read Hindi / English
- •Ability and willingness to complete all study visits and procedures; in particular an agreement to engage with trying to use the device per the study protocol
- •Ability and willingness to adhere to 30 minutes usage of the device at 5 days per week for the duration of the trial at clinic
- •Agree not to undergo any extreme lifestyle changes during the duration of the study that could impact sleep e.g. dietary or exercise changes
排除标准
- •Patient Health Questionnaire-9 (PHQ-9) score of <10 at screening
- •Risk of persistent self-harm or suicide
- •Diagnosis or history of bipolar disorder
- •History of a current psychotic disorder such as schizophrenia or other non-mood disorder psychosis
- •Diagnosis of substance use disorder or dependence
- •Use of recreational drugs (e.g nalgesics, depressants, stimulants, and hallucinogens). Subject can enrol after a washout period of 30 days
- •History of diagnosed cognitive impairment / disorder such as delirium or dementia
- •Previous diagnosis of a chronic viral infection, for example hepatitis or HIV.
- •History of stroke or head injury requiring intensive care or neurosurgery
- •Presence of permanently implanted battery-powered medical device or stimulator (e.g., pacemaker, implanted defibrillator, deep brain stimulator, vagal nerve stimulator, etc.)
- •History of epilepsy
- •History of severe tinnitus or vertigo
- •History of skin breakdown, eczema or other dermatological condition (e.g. psoriasis) affecting the skin behind the ears.
- •History or presence of malignancy within the last year (except basal and squamous cell skin cancer and in-situ carcinomas)
- •History of vestibular dysfunction or another inner ear disease
- •Regular use (more than twice a month) of antihistamine medication within the last 6 months
- •A diagnosis of myelofibrosis or myelodysplastic syndrome
- •Diagnosis of active migraines
- •Previous use of Modius device or any VeNS device
- •Participation in other clinical trials sponsored by Neurovalens
- •Any other medical condition, or medication use, that in the opinion of the PI is likely to make the subject refractory to VeNS.
- •Failure to use device daily during trial participation (no more than 14 consecutive days usage drop without reasonable explanation)
结局指标
主要结局
To evaluate the ability of the Modius Mood device, relative to the sham control group, in reducing the severity of depression at 8 weeks
时间窗: 8 weeks
Change in the Beck's Depression Inventory (BDI) score from baseline to 8 weeks between the active and control group.
次要结局
- To evaluate the impact of the Modius Mood device, relative to the control group, on anxiety at 4 weeks and 8 weeks(8 weeks)
- To evaluate the impact of the Modius Mood device, relative to the control group, on insomnia at 4 weeks and 8 weeks(8 weeks)
- To evaluate the ability of the Modius Mood device, relative to the sham control group, in reducing the severity of depression at 2, 4 and 6 weeks(8 weeks)
- To evaluate the effect of the Modius Mood, relative to control group, on quality of life at 4 weeks and 8 weeks(8 weeks)